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BladderScan® BVI 6000 Series

by Verathon Inc 2 variants

Ref 0570-0355

BladderScan BVI 6000 Series (0570-0355) is a bladder ultrasound imaging transducer (EU MDR Class IIa; FDA Class II) made by Verathon Inc, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 087912300-0011JV), cleared under FDA 510(k) K022153 on 15 Aug 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00879123005564), active as of 8 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K022153

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number087912300-0011JV Basic UDI-DI 00879123005564UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123005564 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK022153 Date15 Aug 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 087912300-0011JV registered 14 Oct 2026 Active
  • FDA 510(k) K022153 decided 15 Aug 2002 Active
  • FDA GUDID UDI-DI 00879123005564 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0143-2011 FDA Unclassified (pre-2012) initiated 20 Sep 2010

    Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.

Timeline

4 dated events

  1. Cleared FDA 510(k) K022153
  2. Recall initiated FDA recalls Z-0143-2011
  3. Listed FDA GUDID 00879123005564
  4. Registered EUDAMED 087912300-0011JV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
BladderScan BVI 6100 EUDAMED
BladderScan® GUDID
Generic name
Bladder ultrasound imaging transducer
Device name
Bladder Volume Measurement Ultrasound Probes & Consoles
Model / Ref / Catalog
0570-0355, BVI 6000 Series
Primary DI / UDI-DI
00879123005564
Basic UDI-DI
087912300-0011JV
510(k) Number
FDA product code
IYO, ITX
EMDN code
Z12080304 Ultrasonic bladder volume scanners
GMDN term
Bladder ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0570-0355
GUDID
BVI 6000 Series
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bladder ultrasound imaging transducer

Cleared under the same submission (K022153)

and 4 more cleared under K022153

Similar devices in this category

Other devices filed under ULTRASONIC BLADDER VOLUME SCANNERS.

Other devices from Verathon Inc

See all devices from Verathon Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)